Events

Rappel de Device Recall TRYPTIK(R) 2 CPLATE SELFTAPPING POLYAXIAL SCREW

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par SPINEART SA.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    78640
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0338-2018
  • Date de mise en oeuvre de l'événement
    2017-11-27
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160052
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Appliance, fixation, spinal intervertebral body - Product Code KWQ
  • Cause
    Product labeling for tryptik 2-c-plate self tapping screw, ref try-ps 40, lot 3-5934 contains the sketch/drawing of a self-drilling screw.
  • Action
    Spineart sent an Urgent Medical Device letter by email dated November 27, 2017. The letter stated the following: "Out of an abundance of caution", we have decided to recall the concerned products. Please carefully follow instructions detailed below: 1. Immediately examine your inventory and quarantine product subject to recall. 2. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall by using this document. 3. Collect and quarantine all products. 4. Send back all products and the enclosed Response Form to Spineart Geneva E-mail: regulatory@spineart.com." For further questions, please call (949) 313-6400..

Device

Device Recall TRYPTIK(R) 2 CPLATE SELFTAPPING POLYAXIAL SCREW
  • Modèle / numéro de série
    batch: 3-5935
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Distribution to the state of : CA
  • Description du dispositif
    TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 16 MM, REF TRY-PS-40 16-S, Qty 2 || TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions.
  • Manufacturer
    SPINEART SA

Manufacturer

SPINEART SA
  • Adresse du fabricant
    SPINEART SA, route de Pre bois 20, Case Postale 1813, Geneva 15 Switzerland
  • Société-mère du fabricant (2017)
    Spineart Sa
  • Source
    USFDA